Responsiveness and Minimal Important Change of Two Measures of Pain Intensity in People With Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- Gauge of pain
研究概览
简要总结
This is an observational study aimed at evaluating the responsiveness and minimal important change of two measures of pain intensity in people with low back pain. It consists of a battery of self-administered questionnaires which will be given to individuals with low back pain to complete before and after a rehabilitation treatment. Relationships among the different outcome measures will be also evaluated.
详细描述
This is an observational study aimed at evaluating the responsiveness and minimal important change of two different graphical ways to assess pain intensity in people with low back pain.
Literature found out that low back pain intensity is commonly assessed by a numerical rating scale ranging from no pain to the worst imaginable pain, once presented to responders horizontally. A different way to assess pain intensity could be to answer a similar numerical rating scale if set vertically.
In Literature there are not studies which head-to-head evaluate the responsiveness and minimal important change of these two ways of assessing pain intensity due to low back pain.
Participants will also have to complete self-reported outcome measures of disability, catastrophizing, fear of movement and self-efficacy, and correlations among these tools and the above two different ways to evaluate pain intensity will be evaluated. Descriptive statistics will be presented by taking into account the socio-demographic characteristics of the sample under investigation.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Non specific low back pain
- •Adult age
- •Ability to understand the Italian language
排除标准
- •Refuse to adhere to the study
- •Definite causes of low back pain
- •Central or peripheral neurological signs
- •Systemic illness or psychiatric deficits
- •Recent myocardial infarction, cerebrovascular events, or chronic lung or renal diseases
结局指标
主要结局
Gauge of pain
时间窗: Immediately before the rehab treatment starts and immediately after the intervention
Numerical Rating Scale; score -5/+5 with lower estimates indicating higher levels of pain intensity (vertical line)
NRS
时间窗: Immediately before the rehab treatment starts and immediately after the intervention
Numerical Rating Scale; score 0-10 with higher estimates indicating higher levels of pain intensity (horizontal line)
次要结局
- GPE(Immediately after the intervention)
- ODI(Immediately before the rehab treatment starts and immediately after the intervention)
- PCS(Immediately before the rehab treatment starts and immediately after the intervention)
- PSEQ(Immediately before the rehab treatment starts and immediately after the intervention)
- TSK(Immediately before the rehab treatment starts and immediately after the intervention)